Regulatory Affairs RWE Lead
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Søborg
Do you want to join our team at Novo Nordisk and dive into the dynamic world of Regulatory Affairs? With a patient focus, deep scientific understanding, and expertise in managing diverse stakeholder interests, every day with us is rewarding and intellectually enriching. If you thrive driving several projects and initiatives across functions, we invite you to read more and apply to join our RWE & RA SEMA CVOT team in Søborg/Copenhagen.
The position
As a RA RWE Lead, you will leverage learnings and strategic approaches of integrating RWD/E in development projects, regulatory decision-making, and labelling. As our new RA RWE Lead, you will represent global regulatory affairs (GRA) in various projects and external platforms to shape the Real World Data/Evidence (RWD/E) landscape for regulatory decisions.
Your main responsibilities will include: Plan and conduct of regulatory RWD/E and Semaglutide Outcome Trials’ interactions with health authorities Support projects to prepare and submit of regulatory RWD/E related files and response to questions from health authorities Be responsible for providing regulatory inputs to RWD/E Guidance Documents and RWD/E Interactions with Health Authorities Provide training and share lessons learned and best practice across GRA Qualifications
We are looking for someone that has solid knowledge in regulatory science, clinical development, data generation, medical and disease area understanding. You can interpret clinical data and build strong regulatory science strategies and submission scenarios. To succeed in this role, you will have: Educational background as MD, PharmD, MSc, or PhD Extensive experience working with real world evidence, clinical trials or regulatory affairs Demonstrated experience as a project manager Strong stakeholder management and networking skills Fluent in written and spoken English As a person, you demonstrate proactive leadership style and act with a committed, persistent and accountable behaviour. Your strong change management skills, as well as planning and coordination skills, help you to identify problems and solutions proactively – keeping things simple and eliminate unnecessary complexity.
About the department
RA SEMA is responsible for defining and driving regulatory strategies for our semaglutide & cagrisema projects in all phases of development. We are dedicated and highly engaged employees work as an integrated part of the global development and research projects and play a key role in cross-functional teams. We are responsible for the semaglutide and cagrisema regulatory strategy and provide regulatory expertise and tactics to product development plans. We drive label development, health authority interactions, and clinical trial applications. We have a strong collaboration with our affiliates and global stakeholders in the regulatory teams.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact the Hiring Manager, Helene Nordahl at +45 3075 0291. Deadline
17 March 2024.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
The position
As a RA RWE Lead, you will leverage learnings and strategic approaches of integrating RWD/E in development projects, regulatory decision-making, and labelling. As our new RA RWE Lead, you will represent global regulatory affairs (GRA) in various projects and external platforms to shape the Real World Data/Evidence (RWD/E) landscape for regulatory decisions.
Your main responsibilities will include:
We are looking for someone that has solid knowledge in regulatory science, clinical development, data generation, medical and disease area understanding. You can interpret clinical data and build strong regulatory science strategies and submission scenarios. To succeed in this role, you will have:
About the department
RA SEMA is responsible for defining and driving regulatory strategies for our semaglutide & cagrisema projects in all phases of development. We are dedicated and highly engaged employees work as an integrated part of the global development and research projects and play a key role in cross-functional teams. We are responsible for the semaglutide and cagrisema regulatory strategy and provide regulatory expertise and tactics to product development plans. We drive label development, health authority interactions, and clinical trial applications. We have a strong collaboration with our affiliates and global stakeholders in the regulatory teams.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact the Hiring Manager, Helene Nordahl at +45 3075 0291. Deadline
17 March 2024.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 1.3.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Søborg
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